Sunday, May 20, 2012
Here They Come!
It looks like the European and (with any luck) the US regulators will just about make it in time . . .maybe.
An interesting news article just popped up from Edmonton, Canada where officials are investigating an outbreak of Gram negative bacterial infections resistant to all of our most effective antibiotics. These bacteria were introduced by a patient who had received medical care abroad, but who was not placed in isolation upon admission to the hospital in Edmonton. The patient apparently died of her infection. Several other patients subsequently became infected. An investigation is ongoing and it made the local press and television.
Another article also caught my eye. Dr. Huttner and colleagues examined the use of certain so-called last resort antibiotics between 2005 and 2010 within the 152 hospital VA system in the US. They clearly showed an increasing use of polymyxin (up about 30%) and tigecycline (up over 5 fold) during the years of study. Polymyxin is an antibiotic of questionable efficacy and is associated with frequent kidney and nerve toxicities. Tigecycline (dear to my heart) is limited in the dose that can be used because of gastrointestinal intolerance and it has been shown to work poorly at recommended doses in very seriously ill intensive care unit patients. Nevertheless, both these antibiotics are on the upswing. Why – because more and more patients are being infected by highly resistant Gram-negative pathogens – similar to those causing the outbreak that caught the news in Edmonton Canada. For these infections, there are no other choices.
There is hope. There are antibiotics in the late stage pipeline that will address at least some of these pathogens – but unfortunately not all. The question is – how quickly can they be brought forward? That is the question that the regulators must decide and decide now. And what about those pathogens for which there is little in the current late stage antibiotic pipeline? There are some at earlier stages of development that might be useful. How quickly can these be tested in infected patients? Here again – regulators and sponsors will have to get together and move things along quickly. But the time for infeasible trial designs and a long FDA reboot process is over. The time to act is NOW!